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The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. Two doses will be studied, 2.87 x 10(8) and 2.87 x 10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Ad5FGF-4 |
|
| 2 | Experimental | Ad5FGF-4 |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad5FGF-4 vs. Placebo | Genetic | Intracoronary infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in treadmill exercise duration from baseline | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a =>30% increase in exercise duration compared to baseline | 4 weeks, 12 weeks and 6 months | |
| Number of patients with and time to coronary events or all-cause death | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Foster, MD | Cardium Therapeutics, 12255 El Camino Real #250, San Diego, CA 92130, (858) 436-1000 | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17825712 | Derived | Henry TD, Grines CL, Watkins MW, Dib N, Barbeau G, Moreadith R, Andrasfay T, Engler RL. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007 Sep 11;50(11):1038-46. doi: 10.1016/j.jacc.2007.06.010. Epub 2007 Aug 24. |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
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| Change in treadmill exercise duration compared to baseline | 4 weeks and 6 months |
| Change in time to 1 mm ST segment depression during ETT compared to baseline | 4 weeks, 12 weeks and 6 months |
| Change in time to angina onset during ETT compared to baseline | 4 weeks, 12 weeks and 6 months |
| Change in CCS class compared to baseline | 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months |
| Change in weekly frequency of anginal attacks compared to baseline | 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months |
| Change in weekly PRN nitroglycerin use compared to baseline | 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months |
| Change in quality of life (SAQ, DASI, SF-36, EQ-5D) compared to baseline | 4 weeks, 12 weeks, 6 months and 12 months |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |